CN102971013B - 缀合的凝血因子VIIa - Google Patents

缀合的凝血因子VIIa Download PDF

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Publication number
CN102971013B
CN102971013B CN201180021895.1A CN201180021895A CN102971013B CN 102971013 B CN102971013 B CN 102971013B CN 201180021895 A CN201180021895 A CN 201180021895A CN 102971013 B CN102971013 B CN 102971013B
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CN
China
Prior art keywords
fviia
pharmaceutical composition
factor viia
pegylation
peg
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Expired - Fee Related
Application number
CN201180021895.1A
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English (en)
Chinese (zh)
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CN102971013A (zh
Inventor
W·亨利
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Abzena UK Ltd
Cantab Biopharmaceuticals Patents Ltd
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Polytherics Ltd
Cantab Biopharmaceuticals Patents Ltd
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Application filed by Polytherics Ltd, Cantab Biopharmaceuticals Patents Ltd filed Critical Polytherics Ltd
Publication of CN102971013A publication Critical patent/CN102971013A/zh
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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36Blood coagulation or fibrinolysis factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/48Hydrolases (3) acting on peptide bonds (3.4)
    • A61K38/482Serine endopeptidases (3.4.21)
    • A61K38/4846Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021Intradermal administration, e.g. through microneedle arrays, needleless injectors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/02Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/006General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length of peptides containing derivatised side chain amino acids
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/107General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides
    • C07K1/113General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides without change of the primary structure
    • C07K1/1133General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length by chemical modification of precursor peptides without change of the primary structure by redox-reactions involving cystein/cystin side chains
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Wood Science & Technology (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Diabetes (AREA)
  • Urology & Nephrology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
CN201180021895.1A 2010-04-30 2011-04-28 缀合的凝血因子VIIa Expired - Fee Related CN102971013B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB1007356.7 2010-04-30
GBGB1007356.7A GB201007356D0 (en) 2010-04-30 2010-04-30 Conjugated factor VIIa
PCT/GB2011/000663 WO2011135308A1 (fr) 2010-04-30 2011-04-28 Facteur viia conjugué de coagulation sanguine

Publications (2)

Publication Number Publication Date
CN102971013A CN102971013A (zh) 2013-03-13
CN102971013B true CN102971013B (zh) 2015-01-07

Family

ID=42289986

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201180021895.1A Expired - Fee Related CN102971013B (zh) 2010-04-30 2011-04-28 缀合的凝血因子VIIa

Country Status (28)

Country Link
US (1) US9309507B2 (fr)
EP (1) EP2563403B1 (fr)
JP (2) JP2013525415A (fr)
KR (1) KR20130055620A (fr)
CN (1) CN102971013B (fr)
AP (1) AP2012006574A0 (fr)
AU (1) AU2011247148B2 (fr)
CA (1) CA2796870A1 (fr)
CL (1) CL2012003038A1 (fr)
CO (1) CO6660500A2 (fr)
CR (1) CR20120580A (fr)
DK (1) DK2563403T3 (fr)
EA (1) EA201290941A1 (fr)
EC (1) ECSP12012315A (fr)
ES (1) ES2503570T3 (fr)
GB (2) GB201007356D0 (fr)
HK (1) HK1175999A1 (fr)
IL (1) IL222565A (fr)
MX (1) MX2012012684A (fr)
MY (1) MY160510A (fr)
NI (1) NI201200161A (fr)
NZ (1) NZ603938A (fr)
PE (1) PE20130253A1 (fr)
PL (1) PL2563403T3 (fr)
RU (1) RU2012144554A (fr)
SG (1) SG184573A1 (fr)
WO (1) WO2011135308A1 (fr)
ZA (1) ZA201208988B (fr)

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US8642737B2 (en) 2010-07-26 2014-02-04 Baxter International Inc. Nucleophilic catalysts for oxime linkage
US8809501B2 (en) 2009-07-27 2014-08-19 Baxter International Inc. Nucleophilic catalysts for oxime linkage
HUE028056T2 (en) 2009-07-27 2016-11-28 Baxalta GmbH Blood coagulation protein conjugates
WO2011012850A2 (fr) 2009-07-27 2011-02-03 Lipoxen Technologies Limited Glyco-polysialylation de protéines de coagulation non sanguine
CA2822591C (fr) 2010-12-22 2020-12-29 Baxter International Inc. Materiels et methodes pour la conjugaison d'un derive d'acide gras soluble dans l'eau a une proteine
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WO2014210546A1 (fr) 2013-06-27 2014-12-31 University Of Washington Through Its Center For Commercialization Système polymère biocompatible pour le traitement ciblé de troubles thrombotiques et hémostatiques
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GB201518172D0 (en) 2015-10-14 2015-11-25 Cantab Biopharmaceuticals Patents Ltd Colloidal particles for use in medicine
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Also Published As

Publication number Publication date
AP2012006574A0 (en) 2012-12-31
CN102971013A (zh) 2013-03-13
KR20130055620A (ko) 2013-05-28
MY160510A (en) 2017-03-15
IL222565A0 (en) 2012-12-31
ZA201208988B (en) 2014-02-26
GB2492738A8 (en) 2014-03-05
PE20130253A1 (es) 2013-03-16
PL2563403T3 (pl) 2015-03-31
ECSP12012315A (es) 2013-05-31
MX2012012684A (es) 2013-04-03
US9309507B2 (en) 2016-04-12
EP2563403B1 (fr) 2014-06-18
EA201290941A1 (ru) 2013-04-30
IL222565A (en) 2015-10-29
WO2011135308A1 (fr) 2011-11-03
CR20120580A (es) 2013-04-25
AU2011247148B2 (en) 2014-09-18
DK2563403T3 (da) 2014-09-15
GB2492738A (en) 2013-01-09
CO6660500A2 (es) 2013-04-30
RU2012144554A (ru) 2014-06-10
CL2012003038A1 (es) 2014-01-24
JP2015110636A (ja) 2015-06-18
AU2011247148A1 (en) 2012-12-20
NZ603938A (en) 2013-08-30
HK1175999A1 (en) 2013-08-23
GB2492738B (en) 2014-05-21
ES2503570T3 (es) 2014-10-07
NI201200161A (es) 2013-04-19
US20130129698A1 (en) 2013-05-23
SG184573A1 (en) 2012-11-29
JP2013525415A (ja) 2013-06-20
CA2796870A1 (fr) 2011-11-03
EP2563403A1 (fr) 2013-03-06
GB201007356D0 (en) 2010-06-16
GB201220669D0 (en) 2013-01-02

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Termination date: 20160428